Device product
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Z-2195-2015
Product summary
- Event
- Event 71699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 Units
- Official record key
device-enforcement:Z-2195-2015
Official wording
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
Code information: Model #882470 GEMINI TF 16 Slice (453567983931); Serial Number: 7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226 & 7570.
Distribution pattern: Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.
Derived failure modes
-
Device software or design
software defects in the Tumor LOC software application that may potentially result in